MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO PROCESSOR

Model Number EPK-I5010-US

Device Problem No Display/Image (1183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Pentax medical became aware of a report for an event which occurred in the usa stating, "no image, scope cuts out; getting message that says check scope connection" involving pentax model epk-i5010-us/ub010561-r.Additional information from the user stated the event occurred during pre-inspection check.No further information was provided at the time of the report.The device was returned to pentax for evaluation.Pentax service inspectional findings included: electrical connector with wiring intermittent connection, scope connector handle loose, ball plunger damaged, limit switch actuator plate(2) bent.The device was repaired which included replacement of the following components: ball plunger, cable to limit sw, scope connector assy.

Manufacturer Narrative

Pentax medical will be providing supplemental information after follow up on the event.

Manufacturer Narrative

Correction information: g6: follow up #1.H2:if follow-up, what type? h6: coding changed based on the investigation result (health effect - clinical code, health effect - impact code).

• Brand Name: PENTAX
• Type of Device: VIDEO PROCESSOR
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12351851
• MDR Text Key: 283147062
• Report Number: 9610877-2021-00525
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPK-I5010-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/21/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1